2005/171/EC: Commission Decision of 23 February 2005 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2004 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2005) 293) (Text with EEA relevance)
1. The quantity of controlled substances of Group I (chlorofluorocarbons 11, 12, 113, 114 and 115) subject to Regulation (EC) No 2037/2000 which may be used for essential medical uses in the Community in 2004 shall be 1 428 533,000 ODP (ozone depletion potential) kilograms.
2. The quantity of controlled substances of Group I (chlorofluorocarbons 11, 12, 113, 114 and 115) and Group II (other fully halogenated chlorofluorocarbons) subject to Regulation (EC) No 2037/2000 which may be used for essential laboratory uses in the Community in 2004 shall be 73 336,765 ODP kilograms.
3. The quantity of controlled substances of Group III (halons) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory use in the Community in 2004 shall be 19 268,700 ODP kilograms.
4. The quantity of controlled substances of Group IV (carbon tetrachloride) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory uses in the Community in 2004 shall be 141 834,000 ODP kilograms.
5. The quantity of controlled substances of Group V (1,1,1-trichloroethane) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory uses in the European Union in 2004 shall be 529,300 ODP kilograms.
6. The quantity of controlled substances of Group VII (hydrobromofluorocarbons) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory uses in the Community in 2004 shall be 3,070 ODP kilograms.
7. The quantity of controlled substances of group IX (bromochloromethane) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory uses in the Community in 2004 shall be 13,248 ODP kilograms.
The chlorofluorocarbon metered-dose inhalers (CFC-MDIs) listed in Annex I shall not be placed on markets that have determined CFCs for these products to be non-essential.
During the period 1 January to 31 December 2004 the following rules shall apply:
1.
The allocation of essential medical use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115 shall be to the companies indicated in Annex II.
2.
The allocation of essential laboratory use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115 and other fully halogenated chlorofluorocarbons shall be to the companies indicated in Annex III.
3.
The allocation of essential laboratory use quotas for halons shall be to the companies indicated in Annex IV.
4.
The allocation of essential laboratory use quotas for carbon tetrachloride shall be to the companies indicated in Annex V.
5.
The allocation of essential laboratory use quotas for 1,1,1-trichloroethane shall be to the companies indicated in Annex VI.
6.
The allocation of essential laboratory use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VII.
7.
The allocation of essential laboratory use quotas for bromochloromethane shall be to the companies indicated in Annex VIII.
8.
The essential use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115, other fully halogenated chlorofluorocarbons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobromofluorocarbons and bromochloromethane shall be as set out in Annex IX.
Decision 2004/209/EC is repealed.
References to the repealed Decision shall be construed as references to this Decision.
This Decision is addressed to the following undertakings:
3M Health Care Ltd
3M House Morley Street
Loughborough
Leicestershire LE11 1EP
United Kingdom
Aventis
London Road, Holmes Chapel
Cheshire CW4 8BE
United Kingdom
Bespak PLC
North Lynn Industrial Estate
King's Lynn
Norfolk PE30 2JJ
United Kingdom
Boehringer Ingelheim GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Chiesi Farmaceutici SpA
Via Palermo 26/A
I-43100 Parma
GlaxoSmithKline
Speke Boulevard
Speke
Liverpool L24 9JD
United Kingdom
IG Sprühtechnik GmbH
Im Hemmet 1
D-79664 Wehr
Inyx Pharmaceuticals Ltd
Astmoor Industrial Estate
9 Arkwright Road Runcorn
Cheshire WA7 1NU
United Kingdom
IVAX Ltd
Unit 301 Industrial Park
Waterford
Ireland
Jaba Farmaceutica SA
Rua da Tapada Grande, 2
P-2710-089, Abrunheira Sintra
Laboratorio Aldo Union SA
Baronesa de Maldá 73
Espluges de Llobregat
E-08950 Barcelona
Otsuka Pharmaceuticals (E)
Provenca, 388
E-08025 Barcelona
SICOR SpA
Via Terrazzano 77
I-20017 RHO Milano
Schering-Plough Labo NV
Industriepark 30
B-2220 Heist Op Den Berg
Valvole Aerosol Research Italiana
(VARI) Spa — LINDAL Group Italia
Via del Pino, 10
Olginate (LC)
I-23854 Italia
Valeas SpA Pharmaceuticals
Via Vallisneri, 10
I-20133 Milano
Valois SA
50 avenue de l’Europe
F-78160 Marly-Le-Roi
Acros Organics bvba
Janssen Pharmaceuticalaan 3a
B-2440 Geel
Airbus France
316, route de Bayonne
F-31300 Toulouse
Agfa-Gevaert NV
Septestraat 27
B-2640 Mortsel
Bie & Berntsen
Sandbækvej 7
DK-2610 Rødovre
Biosolove BV
Waalreseweg 17
5554 HA Valkenswaard
The Netherlands
Butterworth Laboratories Ltd
54 Waldegrave Road, Teddington
Middlesex TW11 8NY
United Kingdom
Carl Roth GmbH
Schoemperlenstr. 1—5
D-76185 Karlsruhe
Elcom Group
Okružní 988
CZ-735 14 Orlová — Lutyně
Environnement SA
111, Bld Robespierre
BP 4513
F-78304 Poissy
Fisher Scientific
Bishop Meadow Road
Loughborough LE11 5RG
United Kingdom
Health Protection Inspectorate-Laboratories
Paldiski mnt 81
EE-10617 Tallinn
Honeywell Specialty Chemicals
Wunstorfer Straße 40
Postfach 100262
D-30918 Seelze
Institut scientifique de service public (ISSeP)
Rue du Chéra 200
B-4000 Liège
Institut E. Malvoz (B)
Quai du Barbou, 4
B-4000 Liège
Ineos Fluor Ltd
PO Box 13, The Heath
Runcorn Cheshire WA7 4QF
United Kingdom
Katholieke Universiteit Leuven
Krakenstraat 3
B-3000 Leuven
Laboratoires sérobiologiques
3, rue de Seichamps
F-54425 Pulnoy
LGC Promochem GmbH
Mercatorstr. 51
D-46485 Wesel
Mallinckrodt Baker BV
Teugseweg 20
7418 AM Deventer
The Netherlands
Merck KgaA
Frankfurter Strasse 250
D-64271 Darmstadt
Mikro+Polo d.o.o.
Lackova 78
SLO-2000 Maribor
Panreac Química SA
Riera de Sant Cugat 1
E-08110 Montcada I Reixac (Barcelona)
Rohs Chemie GmbH
Berliner Str. 54
D-53819 Neunkirchen-Seelsheid
Sanolabor d.d.
Leskoškova 4
SLO-Ljubljana
SDS Solvants, Documentation, Synthèses SA
Z.I. de Valdonne, BP 4
F-13124 Peypin
Sigma Aldrich Chemie GmbH
Riedstrasse 2
D-89555 Steinheim
Sigma Aldrich Chimie SARL
80 rue de Luzais
L'Isle-d'Abeau Chesnes
F-38297 St-Quentin-Fallavier
Sigma Aldrich Company Ltd
The Old Brickyard
New Road Gillingham SP8 4XT
United Kingdom
Sigma Aldrich Laborchemikalien
Wunstorfer Straße 40, Postfach 100262
D-30918 Seelze
VWR I.S.A.S.
201, rue Carnot
F-94126 Fontenay-sous-bois
University Of Technology Vienna
Institut of Industrial Electronics and Material Science
Gusshausstrasse 27-29
A-1040 Wien
YA-Kemia Oy — Sigma-Aldrich Finland
Teerisuonkuja 4
FI-00700 Helsinki
Supplementary provisions
ANNEX ISupplementary provisions
ANNEX I
Pursuant to paragraph 3 of Decision XII/2 of the 12th Meeting of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free metered-dose inhalers (MDIs), the following Parties have determined that, due to the presence of suitable non-CFC MDIs, CFCs no longer qualify as ‘essential’ under the Protocol when combined with following products:
Product
Country
Salbutamol
Terbutaline
Fenoterol
Orciprenaline
Reproterol
Carbuterol
Hexoprenaline
Pirbuterol
Clenbuterol
Bitolterol
Procaterol
Beclomethasone
Dexamethasone
Fluinisolide
Fluiticasone
Budesonide
Triamcinolone
Ipratropium bromide
Oxitropium Bromide
Austria
X
X
X
X
X
X
X
X
X
X
X
Belgium
X
X
X
X
X
X
X
X
X
X
X
Czech Republic
X
X
X
X
X
X
X
X
X
X
X
Denmark
X
X
X
X
X
X
X
X
X
X
X
Finland
X
France
X
Germany
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Greece
X
X
X
X
X
X
X
X
X
X
X
Ireland
X
Luxembourg
X
Portugal
X
X
X
X
X
X
X
X
X
X
X
The Netherlands
X
X
X
X
X
X
X
X
X
X
X
Norway
X
X
X
X
X
X
X
X
X
X
X
Sweden
X
UK
X
Source: www.unep.org/ozone/dec12-2-3.pdf
ANNEX IISupplementary provisions
ANNEX II
ESSENTIAL MEDICAL USES
Quota of controlled substances of Group I that may be used in the production of metered-dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases (COPDs) are allocated to:
3M (UK)
Aventis (UK)
Bespak (UK)
Boehringer Ingelheim (DE)
Chiesi (IT)
Glaxo Smith Kline (UK)
IG Sprühtechnik (DE)
Inyx Pharmaceuticals (UK)
IVAX (IE)
Jaba Farmaceutica (PT)
Lab. Aldo-Union (ES)
Otsuka Pharmaceuticals (ES)
Sicor (IT)
Schering-Plough (BE)
V.A.R.I. (IT)
Valeas (IT)
Valois (FR)
ANNEX IIISupplementary provisions
ANNEX III
ESSENTIAL LABORATORY USES
Quota of controlled substances of Group I and II that may be used for laboratory and analytical uses, are allocated to:
Agfa-Gevaert (BE)
Bie & Berntsen (DK)
Butterworth Laboratories (UK)
Biosolve (NL)
Carl Roth (DE)
Elcom Group (CZ)
Environnement SA (FR)
Honeywell Specialty Chemicals (DE)
Ineos Fluor (UK)
Katholieke Universiteit Leuven (BE)
LGC Promochem (DE)
Mallinckrodt Baker (NL)
Merck KGaA (DE)
Mikro + Polo (SI)
Panreac Química (ES)
SDS Solvants (FR)
Sanolabor (SI)
Sigma Aldrich Chemie (DE)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
University Of Technology Vienna (AT)
Ya Kemia Oy — Sigma Aldrich (FI)
ANNEX IVSupplementary provisions
ANNEX IV
ESSENTIAL LABORATORY USES
Quota of controlled substances of Group III that may be used for laboratory and analytical uses are allocated to:
Airbus France (FR)
Butterworth Laboratories (UK)
Ineos Fluor (UK)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
ANNEX VSupplementary provisions
ANNEX V
ESSENTIAL LABORATORY USES
Quota of controlled substances of Group IV that may be used for laboratory and analytical uses, are allocated to:
Acros Organics (BE)
Agfa-Gevaert (BE)
Bie & Berntsen (DK)
Biosolve (NL)
Butterworth Laboratories (UK)
Fisher Scientific (UK)
Health Protection Inspectorate-Laboratories (EE)
Institut E. Malvoz (BE)
Institut Scientifique de Service Public (ISSeP) (BE)
Katholieke Universiteit Leuven (BE)
Laboratoires Sérologiques (FR)
Mallinckrodt Baker (NL)
Merck KGaA (DE)
Mikro + Polo (SI)
Panreac Química (ES)
Rohs Chemie (DE)
SDS Solvants (FR)
Sanolabor d.d. (SI)
Sigma Aldrich Chemie (DE)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
Sigma Aldrich Laborchemikalien (DE)
VWR I.S.A.S. (FR)
YA-Kemia Oy (FI)
ANNEX VISupplementary provisions
ANNEX VI
ESSENTIAL LABORATORY USES
Quota of controlled substances of Group V that may be used for laboratory and analytical uses are allocated to:
Acros Organics (BE)
Agfa-Gevaert (BE)
Bie & Berntsen (DK)
Katholieke Universiteit Leuven (BE)
Mallinckrodt Baker (NL)
Mikro + Polo (SI)
Panreac Química (ES)
Sanolabor d.d. (SI)
Sigma Aldrich Chemie (DE)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
ANNEX VIISupplementary provisions
ANNEX VII
ESSENTIAL LABORATORY USES
Quota of controlled substances of Group VII that may be used for laboratory and analytical uses are allocated to:
Acros Organics (BE)
Ineos Fluor (UK)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
ANNEX VIIISupplementary provisions
ANNEX VIII
ESSENTIAL LABORATORY USES
Quota of controlled substances of Group IX that may be used for laboratory and analytical uses are allocated to:
Ineos Fluor (UK)
Sigma Aldrich Chemie (DE)
Sigma Aldrich Chimie (FR)
ANNEX IXSupplementary provisions
ANNEX IX
(This Annex is not published because it contains confidential commercial information.)
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
